Class II — LumiQuick Diagnostics Inc.
| Recalling firm | LUMIQUICK DIAGNOSTICS, INC. |
|---|---|
| Registered facility | LUMIQUICK DIAGNOSTICS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance. |
| Product | Methadone Test Strip; LumiQuick,. Santa Clara, CA 95054 |
| Quantity | ALL |
| Distribution | Distributed in the states of CA, FL, NJ, TX, and NY. |
| Initiated | 2014-03-04 |
| Classified | 2014-04-07 |
| Terminated | 2014-05-09 |
| Recall number | Z-1380-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — LumiQuick Diagnostics Inc. (Z-1380-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67665/
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